MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ PLASTIC CONCENTRIC LUER-LOCK SYRINGE

Catalog Number 300865

Device Problems Fluid/Blood Leak (1250); Explosion (4006)

Patient Problem Exposure to Body Fluids (1745)

Event Date 01/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd plastipak¿ plastic concentric luer-lock syringe exploded and splattered blood on the patient and the nurse.No serious injury or medical intervention was reported.

Manufacturer Narrative

Investigation summary: it has been received 1 picture for investigation.Upon visual inspection of the picture received it can be observed the syringe barrel has resulted broken during use at barrel edge.Dhr of lot 1709222 has been reviewed not finding any annotation or deviation regarding the alleged defect.(b)(4).It has been determined that this incident resulted due to weakness within the barrel edge of the syringe.Recently, a quality project was completed to reduce the occurrence of this defect.Project# (b)(4) has been completed on september 2018 and as part of this project change in mold structure has been performed to strengthen line where barrels resulted broken.This lot was manufactured on september 2017, so actions have been taken after this lot was manufactured.

Event Description

It was reported that bd plastipak¿ plastic concentric luer-lock syringe exploded and splattered blood on the patient and the nurse.No serious injury or medical intervention was reported.

• Brand Name: BD PLASTIPAK¿ PLASTIC CONCENTRIC LUER-LOCK SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 8190077
• MDR Text Key: 131481601
• Report Number: 3003152976-2018-00558
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 300865
• Device Lot Number: 1709222
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other